Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Hydrocortisone Butyrate Cream 0.1% Recalled by Valeant Pharmaceuticals International Due to Subpotent Drug; for the active, HCB, and preservatives,...

Date: October 2, 2014
Company: Valeant Pharmaceuticals International
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Valeant Pharmaceuticals International directly.

Affected Products

Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15

Quantity: 34,218 tubes

Why Was This Recalled?

Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Valeant Pharmaceuticals International

Valeant Pharmaceuticals International has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report